A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Biological: Pegylated Interferon Alfa-2b

Study type: Interventional

Funder types: Industry

Identifiers

NCT02155322

4031-400

Details and patient eligibility

About

This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Competent to self-administer the subcutaneous injections of PEG-IFN
• Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
• Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
• Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
• For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations

Exclusion criteria

• Mucous membrane melanoma or ocular melanoma
• Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
• Evidence of distant or non-regional lymph node metastases or in-transit metastases
• Disease that cannot be completely surgically resected
• Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
• Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
• Hepatic decompensation
• Thyroid dysfunction not responsive to therapy
• Uncontrolled diabetes mellitus
• Clinically active autoimmune disease
• Clinically active and/or uncontrolled infection, including active hepatitis
• Human immunodeficiency virus (HIV)
• History of neuropsychiatric disorder requiring hospitalization
• Actively abusing alcohol or drugs
• Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
• Medical condition requiring chronic systemic corticosteroids
• Received any experimental therapy within 30 days prior to enrolling in this study
• Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
• Previously received interferon-α for any reason
• Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

PEG-IFN

Experimental group

Description:

6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12)

Treatment:

Biological: Pegylated Interferon Alfa-2b

Biological: Pegylated Interferon Alfa-2b